MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CS #4 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Model Number	5531-G-410-E
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
Patient reported pain, swelling & a limp in her right knee.Patient would like to know if implants are subject to a recall.
Event or Problem Description
Patient reported pain, swelling & a limp in her right knee.Patient would like to know if implants are subject to a recall.
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon p/a cr beaded #4r; cat# 5517f402; lot# hyr7l; tritanium bplate triathlon s4; cat# 5536b400; lot# ctd33721; tritanium patella-symmetric; cat# 5556-l-339; lot# px33pt; it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event.An event regarding instability involving a triathlon insert was reported.The event was not confirmed.Method & results -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: 'i have had the opportunity to review documentation related to pi including the product inquiry summary, an operative report from the primary total knee, laboratory reports and an implant sheet.Arthroplasty in question.The event description from the product inquiry summaries states: patient reports pain, swelling and limp in her right knee.Patient would like to know if implants are subject to recall.The operative report and implant sheet describe an uneventful primary tka, laboratory results were normal.No documentation was provided to provide a reason for, nor confirm, the patients' claims of pain, swelling or limp following a primary tka.Should additional information become available i would be happy to further this assessment.'.-product history review: review of the device history records indicate the devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.The patient would like to know if their implants were involved in a recall.It was confirmed that this part was not involved in a recall.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: X3 TRIATHLON INSERT CS #4 10MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 16319034
• Report Number: 0002249697-2023-00140
• Device Sequence Number: 3140275
• Product Code: JWH
• UDI-Device Identifier: 07613327390452
• UDI-Public: 07613327390452
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2024
• Device Model Number: 5531-G-410-E
• Device Catalogue Number: 5531-G-410-E
• Device Lot Number: JE11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Patient Sex: Female